pharmacopeia
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/api/v1/drug/ofloxacin

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: DNA Gyrase Inhibitors; Topoisomerase 4 Inhibitors.

DNA GyraseTopoisomerase 4

Indications

Sourced from openFDA
  • Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:

Contraindications

Sourced from openFDA
  • Ofloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication (see WARNINGS ).contraindicated

Dosage & administration

Sourced from openFDA

The recommended dosage regimen for the treatment of bacterial conjunctivitis is: Days 1 and 2 Instill one to two drops every two to four hours in the affected eye(s). Days 3 through 7 Instill one to two drops four times daily. The recommended dosage regimen for the treatment of bacterial corneal ulcer is: Days 1 and 2 Instill one to two drops into the affected eye every 30 minutes, while awake. Awaken at approximately four and six hours after retiring and instill one to two drops. Days 3 through 7 to 9 Instill one to two drops hourly, while awake. Days 7 to 9 through treatment completion Instill one to two drops, four times daily.

Warnings & precautions

Sourced from openFDA

NOT FOR INJECTION. Ofloxacin ophthalmic solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye. There are rare reports of anaphylactic reaction/shock and fatal hypersensitivity reactions in patients receiving systemic quinolones, some following the first dose, including ofloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. A rare occurrence of Stevens-Johnson syndrome, which progressed to toxic epidermal necrolysis, has been reported in a patient who was receiving topical ophthalmic ofloxacin. If an allergic reaction to ofloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management, including intubation should be administered as clinically indicated.

Adverse reactions

Sourced from openFDA

Ophthalmic use: The most frequently reported drug-related adverse reaction was transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, chemical conjunctivitis/keratitis, ocular/periocular/facial edema, foreign body sensation, photophobia, blurred vision, tearing, dryness, and eye pain. Rare reports of dizziness and nausea have been received. Refer to WARNINGS for additional adverse reactions. To report SUSPECTED ADVERSE REACTIONS, contact Sentlss at 1--855-473-6847 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Use in specific populations

Sourced from openFDA

Pregnancy: Teratogenic Effects: Ofloxacin has been shown to have an embryocidal effect in rats and in rabbits when given in doses of 810 mg/kg/day (equivalent to 9000 times the maximum recommended daily ophthalmic dose) and 160 mg/kg/day (equivalent to 1800 times the maximum recommended daily ophthalmic dose). These dosages resulted in decreased fetal body weight and increased fetal mortality in rats and rabbits, respectively. Minor fetal skeletal variations were reported in rats receiving doses of 810 mg/kg/day. Ofloxacin has not been shown to be teratogenic at doses as high as 810 mg/kg/day and 160 mg/kg/day when administered to pregnant rats and rabbits, respectively. Nonteratogenic Effects: Additional studies in rats with doses up to 360 mg/kg/day during late gestation showed no adverse effect on late fetal development, labor, delivery, lactation, neonatal viability, or growth of the newborn. There are, however, no adequate and well-controlled studies in pregnant women. Ofloxacin ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pharmacokinetics

Sourced from openFDA
Metabolism
Serum, urine and tear concentrations of ofloxacin were measured in 30 healthy women at various time points during a ten-day course of treatment with ofloxacin ophthalmic solution. The mean serum ofloxacin concentration ranged from 0.4 ng/mL to 1.9 ng/mL.

Approval history

Sourced from openFDA
  • Jul 30, 1993NDANDA019921Allergan
  • May 14, 2004ANDAANDA076513Apotex Inc
  • May 14, 2004ANDAANDA076622Bausch And Lomb
  • Sep 28, 2007ANDAANDA076527Apotex Inc
  • Mar 17, 2008ANDAANDA076128Bausch And Lomb Inc
  • Apr 15, 2008ANDAANDA076407Sentiss
  • Feb 25, 2009ANDAANDA078559Fdc Ltd
  • Apr 29, 2013ANDAANDA202692Altaire Pharms Inc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
7,163 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective3494.9%
  2. 2Eye Pain3474.8%
  3. 3Off Label Use3124.4%
  4. 4Headache2864.0%
  5. 5Pain2813.9%
  6. 6Fatigue2633.7%
  7. 7Nausea2563.6%
  8. 8Arthralgia2483.5%
  9. 9Diarrhoea2463.4%
  10. 10Acute Kidney Injury2433.4%
  11. 11Anxiety2112.9%
  12. 12Dyspnoea2082.9%
  13. 13Renal Failure2082.9%
  14. 14Pyrexia2062.9%
  15. 15Chronic Kidney Disease1942.7%

Literature

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Recent PubMed references pinned to Ofloxacin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 459 ClinicalTrials.gov registrations naming Ofloxacin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Ofloxacin. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

Frequently asked questions

How does Ofloxacin work?
Mechanism-of-action classes: DNA Gyrase Inhibitors; Topoisomerase 4 Inhibitors.
What is Ofloxacin used for?
According to FDA labeling, Ofloxacin carries indications including: Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Ofloxacin?
Ofloxacin is classified as Antiinfectives, Fluoroquinolones, Quinolone Antimicrobial, DNA Gyrase Inhibitors, Topoisomerase 4 Inhibitors, Decreased DNA Integrity, Decreased DNA Replication, Decreased Transcription to RNA.
What are the brand names for Ofloxacin?
Ofloxacin is marketed under brand names including Ocuflox.
What are the contraindications for Ofloxacin?
Ofloxacin labeling lists contraindications including: Ofloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication (see WARNINGS ).. Always consult the full prescribing information and a clinician.
Note. Data for ofloxacin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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